Clopidogrel ratiopharm GmbH

Withdrawn

This medicine's authorisation has been withdrawn

clopidogrel

Overview

On 13 January 2020, the European Commission withdrew the marketing authorisation for Clopidogrel ratiopharm GmbH (clopidogrel) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Archie Samuel s.r.o., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Clopidogrel ratiopharm GmbH was granted marketing authorisation in the EU on 28 July 2009 for prevention of atherothrombotic events. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. 

Clopidogrel ratiopharm GmbH is a generic medicine of Plavix. There are other generic medicinal products of Plavix authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Clopidogrel ratiopharm GmbH is updated to indicate that the marketing authorisation is no longer valid.

Clopidogrel ratiopharm GmbH : EPAR - Summary for the public

Product information

Clopidogrel ratiopharm GmbH : EPAR - Product Information

Clopidogrel ratiopharm GmbH : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Clopidogrel ratiopharm GmbH
• Active substance:
  clopidogrel
• International non-proprietary name (INN) or common name:
  clopidogrel
• Therapeutic area (MeSH):
  • Peripheral Vascular Diseases
  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Stroke
• Anatomical therapeutic chemical (ATC) code:
  B01AC04

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Clopidogrel is indicated in adults for the prevention of atherothrombotic events in:

• patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease;
• patients suffering from acute coronary syndrome:
  • non-ST-segment-elevation acute coronary syndrome (unstable angina or non-Q wave-myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (ASA);
  • ST-segment-elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.

Authorisation details

• EMA product number:
  EMEA/H/C/001165
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Archie Samiel s.r.o.

  Slunná 16; 61700 Brno; Czech Republic

• Marketing authorisation issued:
  28/07/2009
• Withdrawal of marketing authorisation:
  13/01/2020
• Revision:
  12

Assessment history

Changes since initial authorisation of medicine

Clopidogrel ratiopharm GmbH : EPAR - Procedural steps taken and scientific information after authorisation

Clopidogrel ratiopharm GmbH-H-C-1165-A20-09 : EPAR - Assessment Report - Article 20

Adopted

Initial marketing authorisation documents

Clopidogrel ratiopharm GmbH : EPAR - Public assessment report

Summary of positive opinion for Clopidogrel Ratiopharm GmbH